Hepaxa Management of Non-alcoholic Fatty Liver Disease

NCT03801577 | Unknown

• 1 other identifier: CTN01019401
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use.

Conditions

Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis

Keywords

omega-3; nafld; nafl; nash; medical food

Outcome Measures

Primary Outcomes (1)

• The change in liver fat content (hepatic steatosis) from baseline to end of study

  Liver fat will be measured using the "Controlled Attenuation Parameter" from the ultrasound based Fibroscan machine

  6 months

Secondary Outcomes (5)

• Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study

  6 months

• Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study

  6 months

• Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study

  6 months

• Change in Level of plasma triglycerides from baseline to end of study

  6 months

• Change in weight from baseline to end of study

  6 months

Other Outcomes (1)

• Exploratory outcome. Stratification of effect Hepaxa using FLI score

  6 months

Study Arms (1)

Hepaxa

EXPERIMENTAL

Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)

Dietary Supplement: Hepaxa

Interventions

Hepaxa DIETARY_SUPPLEMENT

High concentrate EPA and DHA

Hepaxa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, ≥18 years of age.
• Suspicion of NAFLD
• Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
• A fibroscan elastography score \<9 Kpa (Advanced Fibrosis)

You may not qualify if:

• Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic.
• Significant weight loss (\> 5% body weight) or rapid weight loss (\>1.6 kg/week), within six months of screening.
• Individuals taking prescription or supplemental omega-3 fatty acids.
• Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.

Sponsors & Collaborators

• BASF AS: lead

Study Sites (1)

GI Associates and Endoscopy Center

Flowood, Mississippi, 39232, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Reed Hogan, MD

  GI Associates and Endoscopy Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are screened for eligibility and on consent, historical data from liver fat measurements With CAP scores, will be collected from the previous 6 months. Only subjects With no, or poor response to lifestyle recommendations will be enrolled.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)